FDA Product Code
FDA Product Code HQB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4690
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | Vortex Surgical, Inc. | 2022-11-03 | Traditional | PDF ↗ |
| K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019-12-23 | Traditional | PDF ↗ |
| K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019-05-01 | Traditional | PDF ↗ |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | 2013-11-14 | Special | PDF ↗ |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | 2013-06-26 | Special | PDF ↗ |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | Peregrine Surgical , Ltd. | 2013-04-30 | Special | PDF ↗ |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Synergetics, Inc. | 2012-04-23 | Traditional | PDF ↗ |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | Alcon Research, Ltd. | 2011-10-17 | Traditional | PDF ↗ |
| K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | Nidek Co., Ltd. | 2011-07-27 | Traditional | PDF ↗ |
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR | Nidek Incorporated | 2011-02-23 | Special | PDF ↗ |
| K964380 | LC-250 INFRARED LIGHT COAGULATOR | Nk-Optik America | 1997-01-22 | Traditional | PDF ↗ |
| K954308 | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 | Traditional | PDF ↗ |
| K954307 | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 | Traditional | PDF ↗ |
| K954306 | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 | Traditional | PDF ↗ |
| K923531 | OPTOSCALPEL I LASER SYSTEM | Optomed Corp. | 1993-11-12 | Traditional | PDF ↗ |
| K924090 | THE ENDO OPTIKS MICROPROBE | Endo Optics, Inc. | 1993-02-01 | Traditional | PDF ↗ |
| K922735 | ZIESS ENDOPROBE | Carl Zeiss, Inc. | 1992-07-09 | Traditional | PDF ↗ |
| K882679 | SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | 1988-12-14 | Traditional | PDF ↗ |
| K882441 | SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K881926 | REUSABLE FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-06-06 | Traditional | PDF ↗ |
| K860011 | NIDEK AC-2000 LASER SYSTEM | Nidek, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K844356 | SYSTEM 930 ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1985-05-16 | Traditional | PDF ↗ |
| K844209 | ARGON/KRYPTON LASER SYSTEM 8500 | Cooper Lasersonics, Inc. | 1985-02-06 | Traditional | PDF ↗ |
| K844197 | ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS | Nidek, Inc. | 1984-12-24 | Traditional | PDF ↗ |
| K844198 | ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE | Nidek, Inc. | 1984-12-24 | Traditional | PDF ↗ |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | American Medical Optics | 1984-11-08 | Traditional | PDF ↗ |
| K801877 | SLIT LAMP ATTACHMENT | Cavitron Corp. | 1980-09-16 | Traditional | PDF ↗ |
| K780345 | PHOTOCOAGULATOR LASER | Cavitron Corp. | 1978-05-09 | Traditional | PDF ↗ |
| K772213 | LAMP DELIVERY SYS.-PHOTOCOAGULATION | Varian Assoc., Inc. | 1977-12-13 | Traditional | PDF ↗ |
| K760444 | PHOTOCOAGULATOR, LOG 3 PORTABLE XENON | Varian Assoc., Inc. | 1976-08-26 | Traditional | PDF ↗ |
Product code HQB · Class II · Ophthalmic. Data: openFDA.